Acute Effect of One Single Bout of High Intensity Exercise on the Tendency for Ventricular Arrhythmia

NCT04075253 | Completed

• 1 other identifier: 2018/1592-b
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the acute effect of one single bout of high intensity exercise on the tendency for ventricular arrhythmia.

Conditions

Tachycardia, Ventricular; Defibrillators, Implantable

Keywords

Exercise Training

Outcome Measures

Primary Outcomes (1)

• Tendency for ventricular arrhythmia

  Measured by changes in the number of premature ventricular contractions the first 24 hours after VO2 peak testing compared to the average number of the 48 hours prior to the test. Registered on a 72 hours Holter monitoring

  24 hours

Secondary Outcomes (7)

• Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test)

  24 hours

• Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test)

  24 hours

• Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test)

  24 hours

• Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test)

  24 hours

• Changes in ICD-parameters during a single bout of high intensity exercise (VO2 peak test)

  24 hours

Study Arms (1)

VO2 peak test

EXPERIMENTAL

All participants enrolled in the planned study on physical activity and ventricular arrhythmias and on baseline will complete an exercise treadmill test to determine VO2 peak

Behavioral: VO2 peak testing

Interventions

VO2 peak testing BEHAVIORAL

Exercise on treadmill starts with \~4km/h at 0% inclination before inclination is increased to 4% and speed kept unchanged. Inclination will then be increased with two percent approximately after each minute until exhaustion.

Also known as: Cardiopulmonary Exercise Testing (CPET)

VO2 peak test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with ICD and dilated cardiomyopathy or coronary heart disease as cause for implantation
• ICD implanted at St Olavs hospital, Trondheim

You may not qualify if:

• inability to accomplish the exercise program due to serious comorbidity or to participate in regular training within the next 3 months due to other reasons
• signs of severe cardiac ischemia or persistent ventricular tachycardia during individualized treadmill O2 peak test, which after individual assessment is to be found at risk
• comorbidity where endurance training at more than moderate intensity is discouraged
• severe cardiac valve disease
• planned surgery within the next 3 months
• inability to give informed consent

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Norwegian University of Science and Technology: collaborator

Study Sites (1)

St Olavs Hospital

Trondheim, Norway

Location

MeSH Terms

Conditions

Tachycardia, Ventricular

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Rune Wiseth, MD, Prof

  St. Olavs Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: August 30, 2019
• Study Start: September 2, 2019
• Primary Completion: September 2, 2022
• Study Completion: September 2, 2022
• Last Updated: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: After publication
• Access Criteria: Not yet decided

Locations

NO (1)